Menu
Recruiting NCT05923905

Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients

Phase IV Interventional Sporadic and Familial Amyotrophic Lateral Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FB1006, Placebo.
Who it may be relevant to
Registry conditions: Sporadic and Familial Amyotrophic Lateral Sclerosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients

Overview

This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral sclerosis (ALS) patients.

Detailed description

This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral sclerosis (ALS) patients. The study has two phases: the first phase is 24 weeks, using a randomized double-blind placebo-controlled design; the second phase is 24 weeks, using an open-label study design. FB1006 was approved by the National Medical Products Administration（NMPA）on June 21, 2021.

Interventions

  • Drug FB1006
    30mg/day
  • Drug Placebo
    30mg/day

Primary outcome measures

  • ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score [Time frame: 24 weeks]
Secondary outcome measures (12)
  • ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) Score [Time frame: 24 weeks]
  • ALSFRS-R Score [Time frame: 12 weeks, 36 weeks, and 48 weeks]
  • ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score [Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, and 48 weeks]
  • ALSAQ-40 (Amyotrophic Lateral Sclerosis Assessment Questionnaire-40) Score [Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks]
  • Zung 's Self-Rating Depression Scale [Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, and 48 weeks.]
  • Metabolic Level [Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.]
  • FVC% (Forced Vital Capacity) [Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.]
  • Body Weight [Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.]
  • MRC (Medical Research Council) Scale [Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.]
  • MUNIX (Motor Unit Number Index) [Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.]
  • Language Disorders [Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.]
  • Hand Delicate Function [Time frame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks.]

Eligibility criteria

Inclusion criteria

  • World Federation of Neurology modified El Ecorial criteria for diagnosis of patients with laboratory support probable, clinically probable, or definite sporadic and familial amyotrophic lateral sclerosis (ALS)
  • Age 18 to 80 years old
  • ALS duration no longer than 18 months(from day of onset)
  • Patient 's ALSFRS-R total scored ≥27，Each single item is scored at least 2（dyspnoea, orthopnea and respiratory insufficiency ≥3）
  • Forced vital capacity (FVC%) no less than 70% of predicted normal for gender, height and age
  • According to brain function AI analysis in accordance with depressive EEG characteristics
  • Women and men of childbearing potential should use medically acceptable contraception
  • Voluntarily participate, and sign an informed consent form

Exclusion criteria

  • Patients with dementia or severe neurological, psychiatric or systemic disease that is poorly controlled or may interfere with the conduct of the trial or the results of the trial
  • Pregnant women and lactating women
  • Suicide attempt or attempted suicide
  • Combined with other neurological diseases similar to ALS symptoms, or affecting the evaluation of drug efficacy, such as cervical spondylotic myelopathy, lumbar spondylosis, dementia, etc.
  • Patients with history of spinal surgery after ALS onset
  • ALT or AST > 2 times ULN，creatinine clearance < 60 mL/min/1.73m2 (MDRD)
  • Patients who are allergic to the investigational product
  • Having participated in other clinical studies within 3 months before randomization
  • Patients that the investigator considers unsuitable for participation in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University Third Hospital — Beijing

Identifiers

NCT: NCT05923905 · M2022300

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗